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Sponsored by: |
Simmons Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00622466 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: paclitaxel Drug: sorafenib tosylate Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer |
Estimated Enrollment: | 41 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxil IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically* confirmed breast cancer
Stage IV (metastatic) disease
Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
Primary tumor or metastatic tumor HER2-negative, defined as the following:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Active or uncontrolled medical illness (e.g., active infection > CTCAE grade 2), including any of the following:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior hormonal therapy for MBC or adjuvant or neoadjuvant chemotherapy
United States, Texas | |
Parkland Memorial Hospital | Recruiting |
Dallas, Texas, United States, 75235-7786 | |
Contact: Contact Person 214-648-7021 mishel.davis@utsouthwestern.edu | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
Dallas, Texas, United States, 75390-8852 | |
Contact: Barbara B. Haley, MD 866-460-4673 barbara.haley@utsouthwestern.edu |
Principal Investigator: | Barbara B. Haley, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000587470, SCCC-112007-035, ONYX-SCCC-112007-035, SCCC-02107 |
Study First Received: | February 22, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00622466 |
Health Authority: | Unspecified |
stage IV breast cancer male breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms, Male Paclitaxel Breast Neoplasms |
Sorafenib Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |